Medical Device Network

NXTSTIM’s wearable nerve stimulation device helps manage long-term pain

A real-world study found that 92% of patients reported pain improvement over 18 months upon using FDA-approved NXTSTIM’s EcoAI device.

NXTSTIM has announced 18-month data from a real-world study showing that its wearable transcutaneous electrical nerve and electromyographic stimulation device, EcoAI, can help relieve pain.

The real-world study enrolled 550 adult patients with different pain sites, such as back pain, neck pain, shoulder pain, and knee pain. After 18 months of using EcoAI, 92% of patients reported pain improvement compared to baseline scores. About 66% of the patients showed at least a 40% improvement in visual analogue pain scale scores compared to baseline.

"This is the first large real-world demonstration of using the EcoAI AIML technology combined with remote patient monitoring to show durable outcomes,” said Prachi Patel MD on behalf of study investigators.

“With no adverse events reported and significant pain relief in over 66% of patients out to 18 months, this is a landmark approach to pain care using a front-end electroceutical solution."

The wearable technologies have seen high growth in recent years. As per a GlobalData report, the market size of wearable technology in the medical sector in 2023 is projected to exceed $100bn and is expected to grow at a compound annual growth rate of 15% up to 2030. The neuromodulation market is also projected to grow from being worth approximately $7bn in 2023 to $10.7bn in 2030, as per GlobalData market analysis.

The EcoAI device works by blocking pain signal transmission from the peripheral nervous system to the central nervous system. It has a pre-set choice of programmes based on historical clinical data and evidence. It also uses AI to record patient data and provide individualised patient neurostimulation programmes.

The patient places a gel pad on the body part where they feel pain. Then the patient can control the device via phone using Bluetooth.

The NXSTIM electroceutical device can also serve as a remote patient monitoring tool. It has been cleared for use by the US Food and Drug Administration as a remote monitoring device that delivers transcutaneous electrical nerve stimulation and electrical muscle stimulation.